CSL H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations
A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a CSL H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.
Trial Health
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 16, 2018
October 1, 2009
August 20, 2009
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Safety: occurrence of safety laboratory adverse events (AEs).
Days 0, 8-10, 21 and 29.
Safety: occurrence of vaccine-associated serious adverse events (SAEs).
Throughout the course of the study.
Immunogenicity: proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater, against influenza H1N1 2009 virus at Day 21 following a single dose of H1N1 vaccine combined with or without AS03 adjuvant.
Day 21.
Immunogenicity: proportion of subjects, stratified by age, with 4-fold or greater hemagglutination inhibition (HAI) antibody titer increases against influenza H1N1 2009 virus at Day 21 following a single dose of H1N1 vaccine with or without AS03.
Day 21.
Safety: occurrence of solicited local and systemic adverse events (AEs).
Within 8 days post vaccination (Day 0-7).
Secondary Outcomes (2)
Immunogenicity: proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater against influenza H1N1 2009 virus following 2 doses of H1N1 vaccine combined with or without AS03 adjuvant.
Day 29, Day 42, 6 months (Day 201) and 12 months (Day 386).
Immunogenicity: proportion of subjects, stratified by age, with 4-fold or greater HAI antibody titer increases against influenza H1N1 2009 virus following 2 doses of H1N1 vaccine combined with or without AS03 adjuvant.
Day 29, Day 42, 6 months (Day 201) and 12 months (Day 386).
Study Arms (5)
Group 3: 15 mcg H1N1 vaccine + AS03 adjuvant
EXPERIMENTAL150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
Group 1: 3.75 mcg H1N1 vaccine + AS03 adjuvant
EXPERIMENTAL150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
Group 4: 7.5 mcg H1N1 vaccine unadjuvanted
EXPERIMENTAL150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Group 2: 7.5 mcg H1N1 vaccine + AS03 adjuvant
EXPERIMENTAL150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
Group 5: 15 mcg H1N1 vaccine unadjuvanted
EXPERIMENTAL150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Interventions
AS03 adjuvant administered with 3.75, 7.5, or 15 mcg Inactivated H1N1 Vaccine.
Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly as 7.5 or 15 micrograms per dose. All doses of vaccine with or without adjuvant will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm.
Eligibility Criteria
You may qualify if:
- Are males or non-pregnant females age 18 and older, inclusive.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
- Have erythrocyte sedimentation rate (ESR) less than 30 mm per hour.
- Are able to understand and comply with planned study procedures.
- Provide written informed consent prior to initiation of any study procedures.
You may not qualify if:
- Have a known allergy to eggs or other components of the vaccine (including squalene based adjuvants, thimerosal, neomycin, polymyxin, and chicken protein).
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination if female of childbearing potential or women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (\>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
- Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 386 clinic visit - 365 days after the second vaccination).
- Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination. This is inclusive of seasonal influenza vaccines.
- Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.
- Have a history of severe reactions following previous immunization with influenza virus vaccines.
- Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 3 days prior to vaccination.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 25, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
October 16, 2018
Record last verified: 2009-10